A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo

Vertigo Clinical Trial

Official title:

A Multicenter, Double-Blind, Phase Ⅱ Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo Caused By Posterior Circulation Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299804
• Other study ID #: LEVO-PCIV-2001
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2014
• Last updated: April 14, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2016
• Source: Sihuan Pharmaceutical Holdings Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.

Description:

This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. At the age more than 18 years old male or female;

2. Patients with vertigo caused by Posterior Circulation Infarction.

3. Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;

4. Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);

5. Ability to sign the statements of informed consent;

Exclusion Criteria:

1. Female patients having Pregnant, Lactating or Birth plan recently;

2. Non-posterior circulation infarction patients;

3. Vertigo caused by any other diseases;

4. Long-term alcohol abuse, or drug abuse;

5. Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;

6. History of allergies on Levophencynonate Hydrochloric or these compositions;

7. Participation in another clinical trial in three months;

8. Investigator thought that should be excluded due to other reason;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Drug:
• Levophencynonate Hydrochloric
this drug is M receptor inhibitor
• Placebo
No active ingredient

Locations

Country	Name	City	State
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sihuan Pharmaceutical Holdings Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of vertigo	The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference.	up to 7 days	No
Secondary	Vertigo severity improved(VAS score)	The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.	up to 7 days	No
Secondary	Nerve function improved(NIHSS/MRS score)	The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.	up to 7 days	No